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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01335399
Registration number
NCT01335399
Ethics application status
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
30/09/2022
Titles & IDs
Public title
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
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Scientific title
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
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Secondary ID [1]
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2010-022445-20
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Secondary ID [2]
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CA204-006
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Universal Trial Number (UTN)
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Trial acronym
ELOQUENT - 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Dexamethasone
Other interventions - Elotuzumab (BMS-901608; HuLuc63)
Other interventions - Elotuzumab (BMS-901608; HuLuc63)
Active Comparator: Lenalidomide + Dexamethasone -
Experimental: Lenalidomide + Dexamethasone + Elotuzumab -
Treatment: Drugs: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Treatment: Drugs: Dexamethasone
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Treatment: Drugs: Dexamethasone
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Treatment: Drugs: Dexamethasone
Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Treatment: Drugs: Dexamethasone
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other interventions: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other interventions: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause.
The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.
Censoring rules applied:
Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy.
Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event.
Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment.
Participants without any post-baseline tumor assessments were censored on the date of randomization
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Timepoint [1]
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From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
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Timepoint [1]
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From randomization to primary completion date (approximately 8 years)
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
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Timepoint [2]
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From randomization to the date of death (up to 8 years)
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Secondary outcome [3]
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Mean Change From Baseline of Pain Severity Score and Pain Interference Score
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Assessment method [3]
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Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF).
BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
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Timepoint [3]
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From Baseline to End of Treatment (approximately 8 years)
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Secondary outcome [4]
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Progression Free Survival (PFS) Rate at Specific Time-points
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Assessment method [4]
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PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.
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Timepoint [4]
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From randomization to the specified time-point (up to 5 years)
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
- Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- are not candidates for high-dose therapy plus stem-cell transplantation (SCT)
because of age (= 65 years) or coexisting conditions. Refusal to undergo high
dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject <
65 years old. There must be a comorbidity that prevents SCT for a subject < 65
years old
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Active plasma cell leukemia
- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/09/2021
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Sample size
Target
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Accrual to date
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Final
748
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - 3600 - Garran
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Local Institution - 3607 - Waratah
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Local Institution - 3610 - Westmead
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2605 - Garran
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2298 - Waratah
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2145 - Westmead
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4029 - Herston
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4064 - Milton
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5000 - Adelaide
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5001 - Woodville South
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3065 - Fitzroy
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3199 - Frankston
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3084 - Heidelberg Melbourne
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3690 - Wodonga
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6150 - Murdoch
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6009 - Nedlands
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Recruitment outside Australia
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Gdansk
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Poland
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State/province [110]
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Krakow
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Poland
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Lodz
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Poland
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State/province [112]
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Lublin
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Poland
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Poznan
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Country [114]
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Poland
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Szczecin
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Country [115]
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Poland
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Warszawa
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Poland
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State/province [116]
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Wroclaw
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Romania
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Brasov
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Country [120]
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Romania
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Bucaresti
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Romania
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Bucuresti
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Romania
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Lasi
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Spain
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Badalona-barcelona
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Spain
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Barcelona
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Spain
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La Laguna- Tenerife
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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San Sebastian
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Spain
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Toledo
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Switzerland
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Bern
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Switzerland
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St Gallen
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Switzerland
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Zurich
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Turkey
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Bornova
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Turkey
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Dikimevi
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Turkey
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Inciralti
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Turkey
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Gaziantep
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United Kingdom
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Antrim
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United Kingdom
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Greater London
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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AbbVie
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Ethics approval
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Summary
Brief summary
The purpose of the study is to determine whether the addition of Elotuzumab to
Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01335399
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01335399
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